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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPORT DUO M.R.I. IMPLANTABLE PORT, CHRONOFLEX DUAL-LUMEN, 9.5F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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C.R. BARD, INC. (BASD) -3006260740 POWERPORT DUO M.R.I. IMPLANTABLE PORT, CHRONOFLEX DUAL-LUMEN, 9.5F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR Back to Search Results
Model Number 1829500
Device Problems Difficult to Flush (1251); Suction Problem (2170); Material Protrusion/Extrusion (2979)
Patient Problem Erythema (1840)
Event Date 12/06/2021
Event Type  Injury  
Event Description
It was reported that ten months post port placement procedure, the silicone septum allegedly popped out of the device.It was further reported that the port allegedly had suction and flushing issue.Reportedly patient experienced erythema.The device was removed and replaced.The current status of the patient is unknown.
 
Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.However, a photo was provided for review.The investigation of the reported event is currently underway.(expiration date: 05/2022).
 
Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one powerport mri duo attached to a catheter was returned for evaluation and one electronic photo was provided for review.Visual, microscopic visual and functional evaluation were performed on the returned device.The investigation is confirmed for the reported material protrusion issue as one of the two port septa(right) was partially dislodged and upon infusing the port, leak was noted from the partially dislodged septum and air aspirated upon aspiration.Further during functional evaluation mandrel test was performed were both the port stem passed the mandrel test as the black mark fully inserted into the lumen and the radiographic images shows no blockage of lumens in the region of port stem and the lumens appeared clear.However, the investigation is inconclusive for the reported difficult to flush issue and suction issue as the exact circumstances at the time of the reported event are unknown.Furthermore, the clinical conditions alleged in the complaint cannot be confirmed.The definitive root cause could not be determined based upon available information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiry date: 05/2022), g3 h11: h6 (method, result, conclusion) h11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
 
Event Description
It was reported that ten months post port placement procedure, the silicone septum allegedly popped out of the device.It was further reported that the port allegedly had suction and flushing issue.Reportedly patient experienced erythema.The device was removed and replaced.The current status of the patient is unknown.
 
Event Description
It was reported that approximately ten months post port placement procedure, the silicone septum allegedly popped out of the device.It was further reported that the port allegedly had suction and flushing issue.Reportedly patient experienced erythema.The device was removed and replaced.The current status of the patient is unknown.
 
Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one powerport mri duo attached to a catheter was returned for evaluation and one electronic photo was provided for review.Visual, microscopic visual and functional evaluation were performed on the returned device.The investigation is confirmed for the reported material protrusion issue as one of the two port septa(right) was partially dislodged and upon infusing the port, leak was noted from the partially dislodged septum and air aspirated upon aspiration.Further during functional evaluation mandrel test was performed were both the port stem passed the mandrel test as the black mark fully inserted into the lumen and the radiographic images shows no blockage of lumens in the region of port stem and the lumens appeared clear.However, the investigation is inconclusive for the reported difficult to flush issue and suction issue as the exact circumstances at the time of the reported event are unknown.Furthermore, the clinical conditions alleged in the complaint cannot be confirmed.The definitive root cause could not be determined based upon available information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiry date: 04/2023).H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
 
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Brand Name
POWERPORT DUO M.R.I. IMPLANTABLE PORT, CHRONOFLEX DUAL-LUMEN, 9.5F
Type of Device
PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
Manufacturer (Section D)
C.R. BARD, INC. (BASD) -3006260740
605 north 5600 west
salt lake city 84116
Manufacturer (Section G)
BARD REYNOSA S.A. DE C.V. -9617592
blvd. montebello #1
parque industrial colonial
reynosa, tamaulipas 88780
MX   88780
Manufacturer Contact
judy ludwig
800 w. rio salado pkwy
tempe, AZ 85281
4803032689
MDR Report Key13151739
MDR Text Key283297072
Report Number3006260740-2021-05510
Device Sequence Number1
Product Code LJT
UDI-Device Identifier00801741027185
UDI-Public(01)00801741027185
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K090512
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 04/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/04/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number1829500
Device Catalogue Number1829500
Device Lot NumberREFT1563
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/11/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/05/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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